It is well known that certain physiological manifestations are caused by an accumulation of particular chemicals in the metabolic system. More specifically, skin is an active site of androgen metabolism and responds to the removal of androgens for the treatment of acne and oily skin as discussed in U.S. Pat. No. 4,088,760 Benson et al. There is evidence to indicate that testosterone is involved in the pathogenesis of acne as well as other androgen related conditions.
Another of these conditions is pattern baldness in males wherein hair follicles, primarily on the crown of the head, shrink in size, producing an ever thinner and thinner hair until ultimately many follicles shrink to a point where they can no longer produce a hair, i.e., they become dormant. Individuals expressing pattern baldness begin to lose their hair very early in life, often in their twenties. It is well documented that male pattern baldness is a type of sex-influenced inheritance, with the allele for pattern baldness being dominant in males and recessive in females. As is true of many genetic mechanisms, however, the precise mechanism of regulation is not thoroughly understood.
Over the past several years, extracellular androgen-binding macro molecules have been identified that are distinct from the intracellular androgen-receptors. The best characterized are the testosterone-extradiol binding globulin (TeBG) from serum and the androgen binding protein (ABP) from the testis itself, as disclosed in "Extracellular Androgen Binding Proteins" by Bardin et al in Ann. Rev. Physiol, 1981, pages 189-198. A variety of in vivo studies have suggested that TeGB-bound testosterone is less available for expression of biological activity than is the free steroid, although the number of steroid receptor sites and structural relationships among sub-units thought to be present has not been established.
Neutral salts have pronounced effects on the solubility of globular proteins. These effects are caused by the changes in the tendency of dissociable groups on the protein to ionize, when the concentration of neutral salts is greatly increased, a protein may be completely precipitated, an effect called "salting out". This salting out process seems to rejuvenate hair follicles that are producing a hair, allowing them to return to their normal size. This salting out process also appears to stimulate long dormant follicles (i.e., follicles no longer producing a hair) to again produce a hair and over time grow back to normal size.
Although the absence of circulating androgens is believed fundamentally necessary to counter expression of baldness in males, other factors are also important. Basically, there are two different methods by which biochemical activities are controlled. One is genetic regulation and the other enzymatic regulation. Most often these regulatory mechanisms function as feedback control systems that continually monitor a cell's biochemistry and make corrections as needed. But, on occasion, substances from without also control intracellular biochemical reactions by inhibiting or activating one or more of the intracellular control systems.
My prior U.S. patent application Ser. No. 07/321,216 relates to facilitating hair growth by substantially removing testosterone from a selected area of a person's scalp, using an aqueous shampoo solution containing a dissociable sodium salt. One ingredient of that solution, lecithin, was thought to act principally as an emulsifier. In storage, after two or three months the lecithin began to decompose and the invention began to lose its effectiveness.
I have since discovered that the lecithin in my prior solution was of much greater importance than just working as an emulsifier. The omission of the lecithin from the invention resulted in a serious thinning of the hair growing on the crowns of the heads of men who were the test group for the invention. Contained in the solutions of my prior patent application for the invention was soy-extracted lecithin, which is a mixture of phosphatidyl choline with lesser amounts of phosphatidyl inositol, phosphatidyl serine, phosphatidyl ethanolamine and vitamins A, C and E.
Choline is normally present in animals in the form of phosphatides. It has been shown that humans require from 0.5 to 1.0 grams of choline per day, an order of magnitude more nearly resembling that of individual amino acids rather than that of vitamins. While it is generally believed that a large portion of the choline is present as acetylcholine, a neurotransmitter, a delicate balance is maintained between acetylcholine and choline, a vasodilator, by means of the enzymes choline acetylase and choline esterase which can acetylate to acetylcholine or hydrolyze to free choline when necessary. According to Holland & Grieg (1952), the formation and breakdown of acetylcholine may be related to cell permeability.
It has been shown that young mice deficient in inositol suffer an inhibition of growth and loss of hair, both of which are corrected by inositol supplementation. The spectacled-eyed condition in rats due to loss of hair about the eyes is also a result of inositol insufficiency. No corresponding tests have been found for humans but since inositol is present in both normal rat and normal human hair in about the same ratio as in other tissues one might speculate on additional similarities.
Wide distribution of pantothenic acid in animal and plant tissues is indicative of the fundamental role that pantothenic acid plays in cellular metabolism. In particular, symptoms due to pantothenic acid deficiency in experimental animals are frequently seen in epithelial tissues. Skin symptoms such as cornification, desquamation, and alopecia frequently occur. It is generally believed that pantothenic acid is necessary for the proper metabolism of inositol.
The function of vitamin E in animals remains at best uncertain. It is thought to act as an antioxidant thereby preventing cell membrane damage of the unsaturated fat component. Without vitamin E in the invention, the scalp became dry, scaly and very oily and the hair became quite brittle. Following the inclusion of vitamin E into the invention, the scalp completely recovered from its prior dry, scaly, oily condition and the hair became soft, flexible, and vibrant to the look and touch. Therefore, vitamin E is necessary for the success of this invention.